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    Summary
    EudraCT Number:2021-000670-28
    Sponsor's Protocol Code Number:CLTP001A12201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-07-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-000670-28
    A.3Full title of the trial
    A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension
    Estudio aleatorizado, doble ciego (participante e investigador) y controlado con placebo en el que se investigan la eficacia, la seguridad y la tolerabilidad de LTP001 en participantes con hipertensión arterial pulmonar.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of LTP001 in pulmonary arterial hypertension participants
    Estudio de la eficacia y la seguridad de LTP001 en participantes con hipertensión arterial pulmonar.
    A.4.1Sponsor's protocol code numberCLTP001A12201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05135000
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Operations (TMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34 90 0353036
    B.5.5Fax number34 93 2479903
    B.5.6E-maileecc.novartis@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLTP001
    D.3.2Product code LTP001
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.2Current sponsor codeLTP001
    D.3.9.3Other descriptive nameLTP001
    D.3.9.4EV Substance CodeSUB221265
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLTP001
    D.3.2Product code LTP001
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.2Current sponsor codeLTP001
    D.3.9.3Other descriptive nameLTP001
    D.3.9.4EV Substance CodeSUB221265
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary arterial hypertension
    Hipertensión arterial pulmonar
    E.1.1.1Medical condition in easily understood language
    Disease in which blood vessels (arteries) in the lungs are damaged. This inhibits blood flow and pressure in the lung arteries rises and eventually heart failure develops
    Enfermedad en la que las arterias en los pulmones están dañados. Esto inhibe el flujo sanguíneo y la presión en las arterias pulmonares aumenta y, finalmente, se desarrolla insuficiencia cardíaca.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of LTP001 in participants with pulmonary arterial hypertension
    Evaluar la eficacia de LTP001 en pacientes con hipertensión arterial pulmonar
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of LTP001 on other efficacy measures, Patient reported outcomes and biomarkers
    - To assess the safety and tolerability of LTP001 in participants with PAH
    - To investigate the pharmacokinetics (PK) of LTP001
    • Evaluar el efecto de LTP001 en otras medidas de eficacia, resultados comunicados por el paciente y biomarcadores.
    • Evaluar la seguridad y la tolerabilidad de LTP001.
    • Investigar la farmacocinética (PK) de LTP001.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - History of PAH belonging to one of the following subgroups of the Clinical Classification Group 1 (WHO):
    --> participants with idiopathic pulmonary arterial hypertension (IPAH)
    --> Hereditary pulmonary arterial hypertension
    --> Congenital heart disease (surgically repaired at least 12 months prior to screening)
    --> drug or toxin induced (for example, anorexigen or methamphetamine use)
    - Resting mean pulmonary arterial pressure > 25 mmHg; pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure < 15 mmHg as determined by right heart catheterization
    - Pulmonary Vascular Resistance > 6 Wood unites (480 dynes s/cm5), as determined by right heart catheterization
    - WHO Functional Class II-III
    - 6MWD must be between 150 and 550 m (inclusive).
    - Standard of care therapy which is stable at least 6 weeks prior to RHC and 6MWT assessment

    Other protocol-defined criteria may apply.
    - Antecedentes de HAP de uno de los siguientes subgrupos del grupo 1 de la clasificación clínica de la HAP de la Organización Mundial de la Salud (OMS):
    -- Participantes con hipertensión pulmonar arterial primaria idiopática (HPAPI).
    -- Hipertensión arterial pulmonar hereditaria.
    -- Enfermedad cardíaca congénita (reparada quirúrgicamente al menos 12 meses antes de la selección).
    -- Inducida por fármacos o toxinas (por ejemplo, uso de anorexígenos o metanfetaminas).
    - Presión arterial pulmonar media (PAPm) en reposo >25 mmHg; presión de enclavamiento capilar pulmonar (PECP) o presión telediastólica ventricular izquierda (PTDVI) <15 mmHg determinadas por cateterismo cardíaco derecho (CCD)
    - Resistencia vascular pulmonar (RVP) >6 unidades Wood (480 dinas s/cm5), determinada por cateterismo cardíaco derecho.
    - Clase funcional II-III de la OMS.
    - La 6MWD debe estar entre 150 y 550 m (inclusive).
    - Tratamiento estándar estable al menos 6 semanas antes del CCD y prueba de aptitud de 6MWT

    Para mas criterios ver protocolo
    E.4Principal exclusion criteria
    - Participants with pulmonary hypertension (PH) in the Clinical Classification Groups 2-5 (WHO), and any PAH Group 1 subgroups that were not covered by the inclusion criteria.
    - Participants with a history of left sided heart disease, chronic left sided heart failure, congenital or acquired valvular disease compromising left ventricular function and/or pulmonary venous hypertension or symptomatic coronary disease
    - Participants with obstructive lung disease defined as: FEV1/FVC < 60% and FEV1 < 60% of predicted value after bronchodilator administration as well as participants with moderate or severe restrictive lung disease: Total Lung Capacity < 70% of predicted value.
    - Acute or chronic impairment (other than dyspnea), which would limit the ability to comply with study requirements, including interference with physical activity and execution of study procedures such as 6MWT .

    Other protocol-defined criteria may apply.
    • Participantes con hipertensión pulmonar (HP) de los grupos 2-5 de la clasificación clínica de la OMS y de cualquier subgrupo del grupo 1 de la HAP no incluido en el criterio de inclusión.
    • Participantes con antecedentes de enfermedad cardíaca del lado izquierdo, insuficiencia cardíaca crónica del lado izquierdo, enfermedad valvular congénita o adquirida que afecte a la función ventricular izquierda, hipertensión venosa pulmonar o enfermedad coronaria sintomática
    • Participantes con enfermedad pulmonar obstructiva definida como: FEV1/FVC <60 % y FEV1 <60 % del valor teórico después de la administración de broncodilatadores, así como participantes con enfermedad pulmonar restrictiva moderada o grave: Capacidad pulmonar total <70 % del valor teórico.
    • Deterioro agudo o crónico (excluyendo la disnea) que limite la capacidad de cumplir los requisitos del estudio, incluyendo la interferencia con la actividad física y la ejecución de los procedimientos del estudio como la 6MWT.

    Para más criterios ver protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline PVR at week 25
    Cambio desde la basal en la resistencia vascular pulmonar (RVP) en la semana 25
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 25
    En la semana 25
    E.5.2Secondary end point(s)
    - Change from baseline in 6MWD at week 13 and week 25
    - Right heart catheterization assessments including RV pressures, pulmonary artery pressures, wedge pressure, and cardiac output at week 25
    - Change from baseline in tricuspid annular plane systolic excursion (TAPSE) by echocardiography at week 5, 13 and 25
    - Change from baseline in tricuspid annular systolic velocity (TASV) by echocardiography at week 5, 13 and 25
    - Change from baseline of peak velocity of excursion (RV S') by echocardiography at week 5, 13 and 25
    - Change from baseline in fractional area change (FAC) by echocardiography at week 5, 13 and 25
    - Change from baseline in EmPHasis-10 and PAH-SYMPACT at week 13 and 25
    - AEs, SAEs, vital signs, ECGs, safety laboratory measurements
    - Time to Clinical Worsening
    - Cmax and Tmax (Day 1 and Week 25)
    - Cambio respecto del basal en la prueba de marcha de 6 minutos (6MWD) a la semana 13 y semana 25.
    - Evaluación de cateterismo cardíaco derecho incluyendo presión en ventrículo derecho, presión arterial pulmonar, presión de enclavamiento y gasto cardíaco en la semana 25
    - Cambio respecto del basal en el desplazamiento sistólico del plano del anillo tricuspídeo (TAPSE) por ecocardiografía a las semanas 5, 13 y 25.
    - Cambio respecto del basal de la velocidad sistólica del anillo tricuspídeo (TASV) por ecocardiografía en visita semana 5, semana 13 y semana 25
    - Cambio respecto del basal de la velocidad máxima de excursión (RV S’) por ecocardiografía en visita semana 5, semana 13 y semana 25.
    - Cambio respecto del basal del área fraccional (FAC) por ecocardiografía en visita semana 5, semana 13 y semana 25.
    - Cambio respecto del basal en EmPHasis-10 y PAH-SYMPACT en visita semana 13 y semana 25.
    - Eventos adversos, eventos adversos graves, signos vitales, electrocardiograma, evaluaciones de laboratorio de seguridad.
    - Tiempo hasta el empeoramiento clínico.
    - Concentración máxima y tiempo máximo en Día 1 y semana 25.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At weeks 13 and 25
    At week 25
    At week 5, 13 and 25
    At week 5, 13 and 25
    At week 5, 13 and 25
    At week 5, 13 and 25
    At week 13 and 25
    Baseline to Week 29
    Baseline to Week 29
    Day 1 and week 25
    En la semana 13 y 25
    En la semana 25
    En la semana 5, 13 y 25
    En la semana 5, 13 y 25
    En la semana 5, 13 y 25
    En la semana 5, 13 y 25
    En la semana 13 y 25
    Basal hasta la semana 29
    Basal hasta la semana 29
    Dia 1 y semana 25
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    United States
    Poland
    Netherlands
    Spain
    Germany
    Russian Federation
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    Último paciente, última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participation in an extension trial may be offered to study participants.
    La participación en un ensayo de extensión se puede ofrecer a los participantes del estudio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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